Decentralised clinical trials for medications to reduce the risk of dementia: consensus report and guidance
Abstract Background Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralised clinical trials in dementia. There are many potential benefits associated with decentralised medication trials, but the field is currently lacking specific recommendations for their delivery in the dementia field. Method A modified Delphi method engaged a panel with substantial expertise in dementia trial design and delivery and backgrounds that included neurology, psychiatry, pharmacology and psychology, to develop recommendations for the conduct of decentralised medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations. Result Overall, the recommendations support the delivery of decentralised remote trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations will be presented, spanning aspects of decentralised clinical trials dementia prevention trials in phases 2b‐4, including safety, dispensing, outcome assessment, and data collection. Conclusion With these recommendations we provide an accessible, pragmatic guide for the design and conduct of remote medication trials for the prevention of dementia.
Authors
- Serge Gauthier (ORCID: https://orcid.org/0000-0003-4272-3330)
- Gregory A. Jicha (ORCID: https://orcid.org/0000-0002-7980-2166)
- Carla Abdelnour (ORCID: https://orcid.org/0000-0002-7636-9758)
- Hiroko H. Dodge (ORCID: https://orcid.org/0000-0001-7290-8307)
- Adesola Ogunniyi (ORCID: https://orcid.org/0000-0002-2946-8956)
- Patrick G. Kehoe (ORCID: https://orcid.org/0000-0002-7542-1139)
- Christopher J. Weber
- Erin L. Abner (ORCID: https://orcid.org/0000-0002-9566-4111)
- Ricardo Allegri (ORCID: https://orcid.org/0000-0001-7166-1234)
- Catherine J. Mummery (ORCID: https://orcid.org/0000-0002-6739-0803)
- Nikolaos Scarmeas (ORCID: https://orcid.org/0000-0001-6453-8908)
- Leanne Howard
- Jodi R. Titiner
- Camilla M. Hoyos (ORCID: https://orcid.org/0000-0002-6543-4016)
- Ruth Peters (ORCID: https://orcid.org/0000-0003-0148-3617)
- Xiaoying Chen (ORCID: https://orcid.org/0000-0002-8367-542X)
- M. Group
Institutions
- Alzheimer's Association (US)
- Harvard University (US)
- University of Kentucky (US)
- University of Ibadan (NG)
- National and Kapodistrian University of Athens (GR)
- UNSW Sydney (AU)
- University of Bristol (GB)
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (AR)
- The George Institute for Global Health (AU)
- National Hospital for Neurology and Neurosurgery (GB)
- University College London (GB)
- McGill University (CA)
- Columbia University (US)
- Stanford University (US)
- Macquarie University (AU)
Publication Details
- Journal
- Alzheimer s & Dementia
- Published
- 2024-12-01
- DOI
- https://doi.org/10.1002/alz.085781
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00